APOQUEL- oclacitinib maleate tablet, coated
apoquel® (oclacitinib tablet)
For oral use in dogs only
Federal (USA) Law restricts this drug to use by or on the order of a licensed veterinarian.
APOQUEL (oclacitinib maleate) is a synthetic Janus Kinase (JAK) inhibitor. The chemical composition of APOQUEL is N-methyl[trans-4-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)cyclohexyl]methanesulfonamide (2Z)-2-butenedioate.
The chemical structure of oclacitinib maleate is:Chemical Structure
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
The dose of APOQUEL (oclacitinib maleate) tablets is 0.18 to 0.27 mg oclacitinib/lb (0.4 to 0.6 mg oclacitinib/kg) body weight, administered orally, twice daily for up to 14 days, and then administered once daily for maintenance therapy. APOQUEL may be administered with or without food.
|Weight Range(in lb)||Weight Range(in Kg)||Number of Tablets to be Administered|
|Low||High||Low||High||3.6 mg Tablets||5.4 mg Tablets||16 mg Tablets|
APOQUEL is not for use in dogs less than 12 months of age (see Animal Safety).
APOQUEL modulates the immune system.
APOQUEL is not for use in dogs with serious infections.
APOQUEL may increase susceptibility to infection, including demodicosis, and exacerbation of neoplastic conditions (see Precautions , Adverse Reactions , Post-Approval Experience and Animal Safety).
New neoplastic conditions (benign and malignant) were observed in dogs treated with APOQUEL during clinical studies and have been reported in the post-approval period (see Adverse Reactions and Post-Approval Experience).
Consider the risks and benefits of treatment prior to initiating APOQUEL in dogs with a history of recurrent serious infections or recurrent demodicosis or neoplasia (see Adverse Reactions , Post-Approval Experience , and Animal Safety).
Keep APOQUEL in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.
This product is not for human use. Keep this and all drugs out of reach of children. For use in dogs only. Wash hands immediately after handling the tablets. In case of accidental eye contact, flush immediately with water or saline for at least 15 minutes and then seek medical attention. In case of accidental ingestion, seek medical attention immediately.
Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.
The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppresive agents.
APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches.
In a masked field study to assess the effectiveness and safety of oclacitinib for the control of atopic dermatitis in dogs, 152 dogs treated with APOQUEL and 147 dogs treated with placebo (vehicle control) were evaluated for safety. The majority of dogs in the placebo group withdrew from the 112-day study by Day 16. Adverse reactions reported (and percent of dogs affected) during Days 0-16 included diarrhea (4.6% APOQUEL, 3.4% placebo), vomiting (3.9% APOQUEL, 4.1% placebo), anorexia (2.6% APOQUEL, 0% placebo), new cutaneous or subcutaneous lump (2.6% APOQUEL, 2.7% placebo), and lethargy (2.0% APOQUEL, 1.4% placebo). In most cases, diarrhea, vomiting, anorexia, and lethargy spontaneously resolved with continued dosing. Dogs on APOQUEL had decreased leukocytes (neutrophil, eosinophil, and monocyte counts) and serum globulin, and increased cholesterol and lipase compared to the placebo group but group means remained within the normal range. Mean lymphocyte counts were transiently increased at Day 14 in the APOQUEL group.
Dogs that withdrew from the masked field study could enter an unmasked study where all dogs received APOQUEL. Between the masked and unmasked study, 283 dogs received at least one dose of APOQUEL. Of these 283 dogs, two dogs were withdrawn from study due to suspected treatment-related adverse reactions: one dog that had an intense flare-up of dermatitis and severe secondary pyoderma after 19 days of APOQUEL administration, and one dog that developed generalized demodicosis after 28 days of APOQUEL administration. Two other dogs on APOQUEL were withdrawn from study due to suspected or confirmed malignant neoplasia and subsequently euthanized, including one dog that developed signs associated with a heart base mass after 21 days of APOQUEL administration, and one dog that developed a Grade III mast cell tumor after 60 days of APOQUEL administration.
One of the 147 dogs in the placebo group developed a Grade I mast cell tumor and was withdrawn from the masked study. Additional dogs receiving APOQUEL were hospitalized for diagnosis and treatment of pneumonia (one dog), transient bloody vomiting and stool (one dog), and cystitis with urolithiasis (one dog).
In the 283 dogs that received APOQUEL, the following additional clinical signs were reported after beginning APOQUEL (percentage of dogs with at least one report of the clinical sign as a non-pre-existing finding): pyoderma (12.0%), non-specified dermal lumps (12.0%), otitis (9.9%), vomiting (9.2%), diarrhea (6.0%), histiocytoma (3.9%), cystitis (3.5%), anorexia (3.2%), lethargy (2.8%), yeast skin infections (2.5%), pododermatitis (2.5%), lipoma (2.1%), polydipsia (1.4%), lymphadenopathy (1.1%), nausea (1.1%), increased appetite (1.1%), aggression (1.1%), and weight loss (0.7).
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